Developing a Exercise Program for Patients Undergoing Hematopoietic Stem Cell Transplantation

NCT06907004 | Completed

• 1 other identifier: 11111-006
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Hematopoietic stem cell transplantation (HSCT) is a highly aggressive treatment, which is associated with numerous treatment-related side effects, such as fatigue and decreased functional activity. While recent studies have shown that physical exercise for patients undergoing HSCT is safe and feasible, and has a positive effect on the quality of life, fatigue, and lower limb muscle strength. However, there is no consensus regarding the intensity, type and frequency of exercise program, and few studies mention the patients' experience of exercise barriers and facilitators during HSCT. Therefore, the clinical implementation of exercise program is quite difficult. Purpose: The purpose of this study is to develop a feasible exercise program for hospitalized patients undergoing hematopoietic stem cell transplantation. Methods: Action Research is used to collect quantitative and qualitative data. Through the rolling revision of the exercise program during HSCT, finally develop a feasible exercise program. Expected results: Developing a feasible exercise program for hospitalized patients undergoing hematopoietic stem cell transplantation.

Conditions

Hematopoietic Stem Cell Transplantation

Keywords

Action research; Hematopoietic stem cell transplantation; Exercise program

Outcome Measures

Primary Outcomes (3)

• Exercise adherence rate

  Definition: The percentage of prescribed exercise sessions completed by participants during the hematopoietic stem cell transplantation hospitalization period. Measurement Method: 1. Numerator: Number of completed exercise sessions 2. Denominator: Total number of prescribed exercise sessions 3. Unit of Measure: Percentage (%)

  approximately 4-6 weeks

• Patient Satisfaction Score of the Exercise Program

  Definition: The mean score of a 7-item satisfaction questionnaire using a 5-point Likert scale to evaluate patient's satisfaction with the exercise program. Measurement Method: 1. Tool: 7-item satisfaction questionnaire with 5-point Likert scale Scale Range: 1 (strongly disagree) to 5 (strongly agree) 2. Total Score Calculation: Mean score of all 7 items 3. Unit of Measure: Score on a scale (1-5) Questionnaire Items: 1. Appropriateness of exercise timing 2. Appropriateness of exercise intensity 3. Appropriateness of exercise frequency 4. Appropriateness of exercise type and difficulty level 5. Achievement of exercise goals 6. Satisfaction with personal performance 7. Willingness to continue exercising

  approximately 4-6 weeks

• Exercise-Related Adverse Events Rate

  Definition: The percentage of exercise sessions with adverse events during the hematopoietic stem cell transplantation hospitalization period. Measurement Method: 1. Numerator: Number of exercise sessions with adverse events 2. Denominator: Total number of completed exercise sessions 3. Unit of Measure: Percentage (%)

  approximately 4-6 weeks

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

First-time hematopoietic stem cell transplantation (HSCT) patients and their primary caregivers, and physical therapists and nurses at Chimei Medical Center.

You may qualify if:

• First-time hematopoietic stem cell transplantation (HSCT) patients who are ambulatory, their primary caregivers, and physical therapists and nurses participating in the exercise intervention;
• Age 20 years or older;
• Capable of understanding and complying with the study objectives;
• No psychiatric disorders or cognitive impairments.

You may not qualify if:

• HSCT patients deemed unsuitable for exercise participation based on the attending physician's assessment;
• HSCT patients at risk of fractures or confined to bed rest due to musculoskeletal conditions.

Sponsors & Collaborators

• Chimei Medical Center: lead

Study Sites (1)

Chimei Medical Center

Tainan, Taiwan, 71004, Taiwan

Location

Related Publications (6)

• Morishita S, Nakano J, Fu JB, Tsuji T. Physical exercise is safe and feasible in thrombocytopenic patients with hematologic malignancies: a narrative review. Hematology. 2020 Dec;25(1):95-100. doi: 10.1080/16078454.2020.1730556.

  PMID: 32075567 BACKGROUND

• Morishita S, Kaida K, Setogawa K, Kajihara K, Ishii S, Ikegame K, Kodama N, Ogawa H, Domen K. Safety and feasibility of physical therapy in cytopenic patients during allogeneic haematopoietic stem cell transplantation. Eur J Cancer Care (Engl). 2013 May;22(3):289-99. doi: 10.1111/ecc.12027. Epub 2012 Dec 18.

  PMID: 23252444 BACKGROUND

• Mohammed J, Aljurf M, Althumayri A, Almansour M, Alghamdi A, Hamidieh AA, ElHaddad A, Othman TB, Bazarbachi A, Almohareb F, Alzahrani M, Alkindi SS, Alsharif F, Da'na W, Alhashmi H, Bekadja MA, Al-Shammari SH, El Quessar A, Satti TM, Aljohani N, Rasheed W, Ghavamzadeh A, Chaudhri N, Hashmi SK. Physical therapy pathway and protocol for patients undergoing hematopoietic stem cell transplantation: Recommendations from The Eastern Mediterranean Blood and Marrow Transplantation (EMBMT) Group. Hematol Oncol Stem Cell Ther. 2019 Sep;12(3):127-132. doi: 10.1016/j.hemonc.2018.12.003. Epub 2019 Jan 11.

  PMID: 30653940 BACKGROUND

• Liang Y, Zhou M, Wang F, Wu Z. Exercise for physical fitness, fatigue and quality of life of patients undergoing hematopoietic stem cell transplantation: a meta-analysis of randomized controlled trials. Jpn J Clin Oncol. 2018 Dec 1;48(12):1046-1057. doi: 10.1093/jjco/hyy144.

  PMID: 30277514 BACKGROUND

• Knols RH, de Bruin ED, Uebelhart D, Aufdemkampe G, Schanz U, Stenner-Liewen F, Hitz F, Taverna C, Aaronson NK. Effects of an outpatient physical exercise program on hematopoietic stem-cell transplantation recipients: a randomized clinical trial. Bone Marrow Transplant. 2011 Sep;46(9):1245-55. doi: 10.1038/bmt.2010.288. Epub 2010 Dec 6.

  PMID: 21132025 BACKGROUND

• Campbell KL, Winters-Stone KM, Wiskemann J, May AM, Schwartz AL, Courneya KS, Zucker DS, Matthews CE, Ligibel JA, Gerber LH, Morris GS, Patel AV, Hue TF, Perna FM, Schmitz KH. Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable. Med Sci Sports Exerc. 2019 Nov;51(11):2375-2390. doi: 10.1249/MSS.0000000000002116.

  PMID: 31626055 BACKGROUND

Related Links

• Physical Activity Guidelines for Taiwanese

Study Officials

• Min-Syuan Yen, Master's Degree

  Chimei Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: April 2, 2025
• Study Start: February 14, 2023
• Primary Completion: October 13, 2023
• Study Completion: October 13, 2023
• Last Updated: April 2, 2025

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)